Relationship Between the Activity of Rheumatoid Arthritis and Lymph Node Morphology and Lymphatics Drainage
the Relationship Between the Activity of Rheumatoid Arthritis(RA) and Popliteal/Epitrochlear Lymph Node Morphology and the Drainage of Hand/Foot Superficial Lymphatic Vessels
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Contacts and Locations
Study Contact
Study Contact
- Name: Qianqian Liang, Dr.
- Phone Number: 86-021-64875390
- Email: liangqianqiantcm@126.com
Study Locations
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Shanghai, China, 200032
- Recruiting
- Longhua Hospital, Shanghai university of TCM
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Shanghai
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Shanghai, Shanghai, China, 200032
- Recruiting
- Longhua Hospital, Shanghai university of TCM
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients fulfilling the classification criteria of American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2009 (scores more than 6 points)
- Health participants normal in the test of blood/urine/stool routine, liver and kidney functions, electrocardiogram and without obvious medical history
- Age 18 to 65 years
- Fulling understood the whole trial and written informed consent.
Exclusion Criteria:
Participants will be excluded when they combined with:
- other types of autoimmune diseases such as ankylosing spondylitis, systemic lupus erythematosus, scleroderma, etc.,
- lymphatic system disorders, such as lymphoma, lymphangitis and lymphatic edema due to lymphatic flow disorders,
- disorders that effect the circulation of lymph or blood vessels such as hemangiomas,
- tumors or cancer,
- operation history within a year, such as joint orthopedics, tumor resection, etc.,
- allergies or allergic to iodine, or radioactive iodine treatment within the last year,
- with metal objects inside, such as pacemakers or nails,
- the skin for the ultrasound inspection not intact such as eczema,ulceration, etc.,
- lactation or pregnancy women or preparation to be pregnant within the next half year,
- without whole limbs to inspect,
- mania, depression or other mental disorder
- medical disorders such as diabetes, hypertension or hyperlipidemia, etc.,
- a history of infectious diseases such as tuberculosis, hepatitis B or HIV, etc.,
- a history of drug abuse such as opioid analgesics, sedative-hypnotics or alcohol abuse, etc.,
- severe liver or kidney dysfunction (Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) two times higher than the upper limit of normal, serum creatinine levels more than two times the upper limit of normal);
- poor compliance.
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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the patients group
0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR
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ICG will be injected into the dorsal of hand/foot
Other Names:
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the health group
0.1ml, 5mg/ml indocyanine green(ICG) will be injected subcutaneously to aid visualization in NIR
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ICG will be injected into the dorsal of hand/foot
Other Names:
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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T-initial
Time Frame: after the injection of ICG from the first day to the fourth day after
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the time that it takes for the ICG to be detected in vessels
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after the injection of ICG from the first day to the fourth day after
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Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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S-max
Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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the maximum ICG signal intensity observed in the target lymph node during the first day imaging session
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after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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T-max
Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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the time it takes for a nodes in cubital fossa or popliteal space to achieve maximal ICG signal intensity
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after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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%Clearance
Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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an assessment of ICG wash out through the lymphatics and is quantified as the percent difference of ICG signal intensity between the two ICG-NIR images from a certain region at a) S-max (first day) and b) 24 hours post ICG injection,
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after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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Pulse
Time Frame: after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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ICG pulses that pass the a certain region within 400 seconds.
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after the injection of ICG, 1day after, 2 days after, 3 days after and 4days after
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lymphatic node size
Time Frame: the second day after enrollment
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the second day after enrollment
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lymphatic node shape
Time Frame: the second day after enrollment
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the second day after enrollment
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lymphatic node transverse/longitudinal diameter ratio
Time Frame: the second day after enrollment
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the second day after enrollment
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lymphatic node types of edges
Time Frame: the second day after enrollment
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the second day after enrollment
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lymphatic node thickness of cortex/medulla
Time Frame: the second day after enrollment
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the second day after enrollment
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lymphatic node homogeneity
Time Frame: the second day after enrollment
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the second day after enrollment
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lymphatic node hilum
Time Frame: the second day after enrollment
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the second day after enrollment
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lymphatic node blood flow signal
Time Frame: the second day after enrollment
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the second day after enrollment
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Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ANTICIPATED)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- RA and lymphatic vessels
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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